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3M MDA 2
Listeria
species and
L. monocytogenes
Collaborative Study
OMA-2016-MONTH-XXX
5/4/16
The 3M MDA2 -
Listeria monocytogenes
method may generate
Listeria
monocytogenes
to levels sufficient to cause stillbirths and fatalities in
pregnant women and the immuno compromised, if exposed. The user must
train its personnel in current proper testing techniques: for example, Good
Laboratory Practices, ISO 17025, or ISO 7218.
Follow all instructions carefully. Failure to do so may lead to inaccurate
results. The 3M Molecular Detection Instrument is intended for use with
samples that have undergone heat treatment during the assay lysis step, which
is designed to destroy organisms present in the sample. Samples that have not
been properly heat treated during the assay lysis step may be considered a
potential biohazard and should NOT be inserted into the 3M MDS
(instrument).
Store the 3M MDA2 -
Listeria monocytogenes
at 2-8°C. Do not freeze. Keep
kit away from light during storage. After opening the kit, check that the foil
pouch is undamaged. If the pouch is damaged, do not use. After opening,
unused reagent tubes should always be stored in the resealable pouch with the
desiccant inside to maintain stability of the lyophilized reagents. Store
resealed pouches at 2-8°C for no longer than 1 month. Do not use 3M MDA
2 -
Listeria monocytogenes
past the expiration date. Expiration date and lot
number are noted on the outside label of the box.
After use, the enrichment medium and the 3M MDA 2 -
Listeria
monocytogenes
tubes can potentially contain pathogenic materials. When
testing is complete, follow current industry standards for the disposal of
contaminated waste. Consult local regulations for disposal.
5.2
Test Kit Reagents -
3M MDA 2 -
Listeria monocytogenes
- 96 tests
5.2.1
Lysis Solution (LS) tubes
. – 96 (12 strips of 8 tubes)
5.2.2
Listeria Reagent tubes
. – 96 (12 strips of 8 tubes)
5.2.3
Extra caps.
– 96 (12 strips of 8 caps)
5.2.4
Reagent Control (RC).
– 16 (2 pouches of 8)
5.2.5
Quick Start Guide
5.3
Additional Supplies and Reagents
5.3.1
3M Molecular Detection System (instrument), power supply, cord, USB
cable and software
5.3.2
3M Molecular Detection Speed Loader Tray
5.3.3
3M Molecular Detection Chill Block Tray and Chill block insert
5.3.4
3M Molecular Detection Heat Block Insert
5.3.5
3M Molecular Detection Cap/Decap Tool [Reagent]
5.3.6
3M Molecular Detection Cap/Decap Tool [Lysis]
5.3.7
Empty lysis tube rack
5.3.8
Empty reagent tube rack
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only